Combination Anticancer Therapy of Paclitaxel and Everolimus for Relapsed or Refractory Small Cell Lung Cancer

A Phase I Study of Combination Anticancer Therapy of Paclitaxel and Everolimus for Relapsed or Refractory Small Cell Lung Cancer

The objective of this phase I study is to determine the maximum tolerated dose (MTD) of combination therapy of paclitaxel and everolimus in small cell lung cancer patient with previous treatment history.

Study Overview

• Status: Completed
• Conditions: Small Cell Lung Cancer
• Intervention / Treatment: Drug: taxol plus everolimus

Detailed Description

Small cell lung cancer (SCLC) accounts for 15% to 20% of all lung cancer, and more than half of these patients are diagnosed with extensive-stage disease (ED). SCLC is a particularly aggressive form of lung cancer with a tendency for rapid tumor growth, early dissemination and high frequency of the metastasis In this study, we evaluate the MTD of everolimus combined with paclitaxel combination chemotherapy in SCLC.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients with histologically or cytologically confirmed small cell lung cancer
2. Regarding a limited disease, the disease in a patient, who had concurrent chemoradiation therapy before, is relapsed or progressing, the patient should have received the first line platinum-based anticancer therapy. The disease should be progressing/relapsed during or after the previous treatment.
3. Regarding an extensive disease, the progression/relapse of the disease during or after the first line platinum-based anticancer therapy should be confirmed.
4. Patient with asymptomatic or treated brain metastasis.
5. Patients without current concomitant chemotherapy
6. Patients without current concomitant radiotherapy
7. Patients who are not receiving chronic treatment with steroids or another immunosuppressive agent.
8. Patients with at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST).
9. Patients aged 18 years or older
10. ECOG performance status 0-2
11. Adequate organ function as evidenced by the following; Absolute neutrophil count > 1.5 x 109/L; platelets > 100 x 109/L; hemoglobin > 9g/dL; -; total bilirubin ≤1.5 UNL; AST and/or ALT < 5 UNL; creatinine clearance ≥ 50mL/min.
12. Patients who signed and dated the informed consent form prior to specific study procedures.
13. Patients who can comply with the scheduled follow-up and toxicity management procedure.'

Exclusion Criteria:

1. Patients with history of treatment with mTOR inhibitors
2. Pregnant with gastrointestinal problem impairing absorption of drugs
3. Patients who could not use appropriate method of contraception
4. Pregnant or feeding patients
5. Other medically ill patients
6. Severe heart/pulmonary disease
7. DM patients
8. Other malignancy except cured skin cancer or uterine cervix carcinoma in situ
9. High cholesterolemia greater than grade 3
10. Patients with symptomatic brain metastasis
11. Chronic hepatitis or liver cirrhosis (patients with HBsAg positive, IgM anti-HBc positive or HCV Ab positive)
12. Patients receiving immunosuppressant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: taxol plus everolimus	Drug: taxol plus everolimus; taxol 175mg/m2 every 3 weeks plus everolimus every day. The dose of everolimus will be started from 2.5mg per day, and increasing to 5mg per day and to 10mg per day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To determine the maximum tolerated dose (MTD) of everolimus when combined with fixed dose of paclitaxel in small cell lung cancer patients	18 months

Secondary Outcome Measures

Outcome Measure	Time Frame
To evaluate the safety when paclitaxel plus everolimus are given to patients with small cell lung cancer	18 months
To evaluate the objective response rate by RECIST 1.1 criteria	18 months

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Principal Investigator: Keunchil Park, M.D., Ph.D, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: February 8, 2010
• First Submitted That Met QC Criteria: March 2, 2010
• First Posted (Estimate): March 3, 2010

Study Record Updates

• Last Update Posted (Estimate): May 30, 2013
• Last Update Submitted That Met QC Criteria: May 29, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: Everolimus; Paclitaxel; Relapsed or Refractory Small Cell Lung Cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Physiological Effects of Drugs; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Everolimus
• Other Study ID Numbers: 2008-10-034